Cumulative radiation dose from medical imaging in paediatric congenital heart disease patients with epicardial cardiac implantable electronic devices.

Aims: To determine whether paediatric congenital heart disease (CHD) patients with epicardial cardiac implantable electronic devices (CIEDs) receive high cumulative effective doses (CEDs) of ionizing radiation from medical imaging tests. Methods and results: We compared 28 paediatric CHD patients with epicardial CIEDs (cases) against 40 patients with no CIED matched by age at operation, sex, surgical era, and CHD diagnosis (controls). We performed a retrospective review of radiation exposure from medical imaging exams between 2006 and 2022. Radiation dose from computed tomography (CT) and X-ray radiography was calculated using the National Cancer Institute Radiation Dosimetry Tool. We performed univariate analysis to compare the CED between the two groups. In the case subgroup, we convened experts' review to adjudicate the prevalence of CT exams that should have been performed with magnetic resonance imaging (MRI) in the absence of a CIED. Children (median age 2.5 years at implant) with CIEDs received significantly higher median CED compared with matched controls (6.90 vs. 1.72 mSv, P = 0.0018). In cases, expert adjudication showed that 80% of the CT exams would have been performed with MRI in the absence of a CIED. This resulted, on average, a five-fold increase in the effective dose (ED) from post-lead implant CTs. Conclusion: Paediatric CHD patients with CIED received four times higher CED than matched controls. Improved access to medical imaging tests without ionizing radiation, such as MRI, could potentially reduce the ED in CIED patients by up to five times.

Determinants of global cardiac implantable electrical device remote monitoring utilization - Results from an international survey.

Background: Despite near-global availability of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED), there is a high geographical variability in the uptake and use of RM. The underlying reasons for this geographic disparity remain largely unknown. Objectives: To study the determinants of worldwide RM utilization and identify locoregional barriers of RM uptake. Methods: An international survey was administered to all CIED clinic personnel using the Heart Rhythm Society global network collecting demographic information, as well as information on the use of RM, the organization of the CIED clinic, and details on local reimbursement and clinic funding. The most complete response from each center was included in the current analysis. Stepwise forward multivariate linear regression was performed to identify determinants of the percentage of patients with a CIED on RM. Results: A total of 302 responses from 47 different countries were included, 61.3% by physicians and 62.3% from hospital-based CIED clinics. The median percentage of CIED patients on RM was 80% (interquartile range, 40-90). Predictors of RM use were gross national income per capita (0.76% per US$1000, 95% CI 0.72-1.00, P < .001), office-based clinics (7.48%, 95% CI 1.53-13.44, P = .014), and presence of clinic funding (per-patient payment model 7.90% [95% CI 0.63-15.17, P = .033); global budget 3.56% (95% CI -6.14 to 13.25, P = .471]). Conclusion: The high variability in RM utilization can partly be explained by economic and structural barriers that may warrant specific efforts by all stakeholders to increase RM utilization.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool.

BACKGROUND AND AIMS: The rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. METHODS: This was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. RESULTS: A total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. CONCLUSIONS: Systemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Conduction System Pacing: Hope, Challenges, and the Journey Forward.

PURPOSE OF THE REVIEW: Cardiac pacing has evolved in recent years currently culminating in the specific stimulation of the cardiac conduction system (conduction system pacing, CSP). This review aims to provide a comprehensive overview of the available literature on CSP, focusing on a critical classification of studies comparing CSP with standard treatment in the two fields of pacing for bradycardia and cardiac resynchronization therapy in patients with heart failure. The article will also elaborate specific benefits and limitations associated with CSP modalities of His bundle pacing (HBP) and left bundle branch area pacing (LBBAP). RECENT FINDINGS: Based on a growing number of observational studies for different indications of pacing therapy, both CSP modalities investigated are advantageous over standard treatment in terms of narrowing the paced QRS complex and preserving or improving left ventricular systolic function. Less consistent evidence exists with regard to the improvement of heart failure-related rehospitalization rates or mortality, and effect sizes vary between HBP and LBBAP. LBBAP is superior over HBP in terms of lead measurements and procedural duration. With regard to all reported outcomes, evidence from large scale randomized controlled clinical trials (RCT) is still scarce. CSP has the potential to sustainably improve patient care in cardiac pacing therapy if patients are appropriately selected and limitations are considered. With this review, we offer not only a summary of existing data, but also an outlook on probable future developments in the field, as well as a detailed summary of upcoming RCTs that provide insights into how the journey of CSP continues.

Remote Monitoring of Cardiac Implantable Electronic Devices in Very Elderly Patients: Advantages and Specific Problems.

Cardiac implantable electronic devices (CIEDs) offer the benefit of remote monitoring and decision making and find particular applications in special populations such as the elderly. Less transportation, reduced costs, prompt diagnosis, a sense of security, and continuous real-time monitoring are the main advantages. On the other hand, less physician-patient interactions and the technology barrier in the elderly pose specific problems in remote monitoring. CIEDs nowadays are abundant and are mostly represented by rhythm control/monitoring devices, whereas hemodynamic remote monitoring devices are gaining popularity and are evolving and becoming refined. Future directions include the involvement of artificial intelligence, yet disparities of availability, lack of follow-up data, and insufficient patient education are still areas to be improved. This review aims to describe the role of CIED in the very elderly and highlight the merits and possible drawbacks.

Infections of cardiac implantable electronic devices and how to improve transvenous lead extraction by the virtual reality.

Introduction: Infections in cardiac implantable electronic devices (CIED) are increasing over time and associated with substantially mortality and healthcare costs. The best approach is the complete removal of the system by transvenous lead extraction (TLE). However, when leads are more than 10 years old, this technique requires considerable expertise and failures with the result of abandoned leads or serious complications may occur. The aim of this study is to describe our experience using virtual and mixed reality in the preoperative planning of complex cases. Patients and methods: Consecutive patients from a referral centre with CIED infections in which TLE was judged difficult. Synchronized computed tomography (CT) scan images were processed and transferred to a fully immersive virtual reality room and also to the operative room (mixed reality) for better guidance during the extracting procedure. Results: Ten patients (seven with local and three with systemic infections) were preoperative evaluated. Processed images and virtual reality showed intense adherences of the leads to the veins, right ventricle, and right atrium endocardium and between them that preclude a difficult extraction and required a carefully planning and sometimes a different technical approach. The anticipated difficulty was confirmed by the higher times of fluoroscopy. All leads were extracted and no complications were registered. Conclusions: Preoperative planning is essential for evaluation of TLE difficulty and prevention of unexpected situations. Virtual reality seems an estimable aid for operators in planning difficult cases and also an excellent tool for teaching. Supplementary information: The online version contains supplementary material available at 10.1007/s12055-023-01663-9.

Infectious mass debulking in lead-associated endocarditis with a percutaneous aspiration system.

AIMS: Debulking of infective mass to reduce the burden if infective material is a fundamental principle in the surgical management of infection. The aim of this study was to investigate the validity of this principle in patients undergoing transvenous lead extraction in the context of bloodstream infection (BSI). METHODS AND RESULTS: We performed an observational single-centre study on patients that underwent transvenous lead extraction due to a BSI, with or without lead-associated vegetations, in combination with a percutaneous aspiration system during the study period 2015-22. One hundred thirty-seven patients were included in the final analysis. In patients with an active BSI at the time of intervention, the use of a percutaneous aspiration system had a significant impact on survival (log-rank: P = 0.0082), while for patients with a suppressed BSI at the time of intervention, the use of a percutaneous aspiration system had no significant impact on survival (log-rank: P = 0.25). CONCLUSION: A reduction of the infective burden by percutaneous debulking of lead vegetations might improve survival in patients with an active BSI.

Contemporary Management of Cardiac Implantable Electronic Device Infection: The American College of Cardiology COGNITO Survey.

Background: Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges. Objectives: The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers. Methods: An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios. Results: Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment. Conclusions: There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes.

Remote monitoring of cardiac implantable electronic devices using smart device interface versus radiofrequency-based interface: A systematic review.

Background: Guidelines recommended remote monitoring (RM) in managing patients with Cardiac Implantable Electronic Devices. In recent years, smart device (phone or tablet) monitoring-based RM (SM-RM) was introduced. This study aims to systematically review SM-RM versus bedside monitor RM (BM-RM) using radiofrequency in terms of compliance, connectivity, and episode transmission time. Methods: We conducted a systematic review, searching three international databases from inception until July 2023 for studies comparing SM-RM (intervention group) versus BM-RM (control group). Results: Two matched studies (21 978 patients) were retrieved (SM-RM arm: 9642 patients, BM-RM arm: 12 336 patients). There is significantly higher compliance among SM-RM patients compared with BM-RM patients in both pacemaker and defibrillator patients. Manyam et al. found that more SM-RM patients than BM-RM patients transmitted at least once (98.1% vs. 94.3%, p < .001), and Tarakji et al. showed that SM-RM patients have higher success rates of scheduled transmissions than traditional BM-RM methods (SM-RM: 94.6%, pacemaker manual: 56.3%, pacemaker wireless: 77.0%, defibrillator wireless: 87.1%). There were higher enrolment rates, completed scheduled and patient-initiated transmissions, shorter episode transmission time, and higher connectivity among SM-RM patients compared to BM-RM patients. Younger patients (aged <75) had more patient-initiated transmissions, and a higher proportion had ≥10 transmissions compared with older patients (aged ≥75) in both SM-RM and BM-RM groups. Conclusion: SM-RM is a step in the right direction, with good compliance, connectivity, and shorter episode transmission time, empowering patients to be in control of their health. Further research on cost-effectiveness and long-term clinical outcomes can be carried out.

Management of Anesthesia for Procedures in the Cardiac Electrophysiology Laboratory.

The complexity of cardiac electrophysiology procedures has increased significantly over the past three decades. Anesthesia requirements of these procedures can be different based on patient- and procedure-specific factors. This manuscript outlines various anesthesia strategies for cardiac implantable electronic devices and electrophysiology procedures including pre-procedural, procedural and post-procedural management. A team-based approach with collaboration between cardiac electrophysiologists and anesthesiologists is required with careful pre-procedural and intra-procedural planning. Given the recent advances in electrophysiology, there is a need for specialized cardiac electrophysiology anesthesia care to improve the efficacy and safety of the procedures.

Safety of magnetic resonance imaging in patients with cardiac implantable electronic devices and abandoned or epicardial leads: a systematic review and meta-analysis.

AIMS: Persistent reluctance to perform magnetic resonance imaging (MRI) in patients with abandoned and/or epicardial leads of cardiac implantable electronic devices is related to in vitro studies reporting tip heating. While there is a plethora of data on the safety of MRI in conditional and non-conditional implantable devices, there is a clear lack of safety data in patients with abandoned and/or epicardial leads. METHODS AND RESULTS: Relevant literature was identified in Medline and CINAHL using the key terms 'magnetic resonance imaging' AND 'abandoned leads' OR 'epicardial leads'. Secondary literature and cross-references were supplemented. For reporting guidance, the Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 was used. International Prospective Register of Systematic Reviews (PROSPERO) registration number 465530. Twenty-one publications with a total of 656 patients with 854 abandoned and/or epicardial leads and 929 MRI scans of different anatomical regions were included. No scan-related major adverse cardiac event was documented, although the possibility of under-reporting of critical events in the literature should be considered. Furthermore, no severe device dysfunction or severe arrhythmia was reported. Mainly transient lead parameter changes were observed in 2.8% in the subgroup of patients with functional epicardial leads. As a possible correlate of myocardial affection, subjective sensations occurred mainly in the subgroup with abandoned epicardial leads (4.0%), but no change in myocardial biomarkers was observed. CONCLUSION: Existing publications did not report any relevant adverse events for MRI in patients with abandoned and/or epicardial leads if performed according to strict safety guidelines. However, a more rigorous risk-benefit calculation should be made for patients with epicardial leads.

Association of a device-based remote management heart failure pathway with outcomes: TriageHF Plus real-world evaluation.

AIMS: Clinical pathways have been shown to improve outcomes in patients with heart failure (HF). Although patients with HF often have a cardiac implantable electronic device, few studies have reported the utility of device-derived risk scores to augment and organize care. TriageHF Plus is a device-based HF clinical pathway (DHFP) that uses remote monitoring alerts to trigger structured telephone assessment for HF stability and optimization. We aimed to evaluate the impact of TriageHF Plus on hospitalizations and describe the associated workforce burden. METHODS AND RESULTS: TriageHF Plus was a multi-site, prospective study that compared outcomes for patients recruited between April 2019 and February 2021. All alert-triggered assessments were analysed to determine the appropriateness of the alert and the workload burden. A negative-binomial regression with inverse probability treatment weighting using a time-matched usual care cohort was applied to estimate the effect of TriageHF Plus on non-elective hospitalizations. A post hoc pre-COVID-19 sensitivity analysis was also performed. The TriageHF Plus cohort (n = 443) had a mean age of 68.8 ± 11.2 years, 77% male (usual care cohort: n = 315, mean age of 66.2 ± 14.5 years, 65% male). In the TriageHF Plus cohort, an acute medical issue was identified following an alert in 79/182 (43%) cases. Fifty assessments indicated acute HF, requiring clinical action in 44 cases. At 30 day follow-up, 39/66 (59%) of initially symptomatic patients reported improvement, and 20 (19%) initially asymptomatic patients had developed new symptoms. On average, each assessment took 10 min. The TriageHF Plus group had a 58% lower rate of hospitalizations across full follow-up [incidence relative ratio: 0.42, 95% confidence interval (CI): 0.23-0.76, P = 0.004]. Across the pre-COVID-19 window, hospitalizations were 31% lower (0.69, 95% CI: 0.46-1.04, P = 0.077). CONCLUSIONS: These data represent the largest real-world evaluation of a DHFP based on multi-parametric risk stratification. The TriageHF Plus clinical pathway was associated with an improvement in HF symptoms and reduced all-cause hospitalizations.

Cardiac Devices and Kidney Disease.

A growing variety of cardiac devices are available to monitor or support cardiovascular function. The entwined nature of cardiovascular disease and kidney disease makes the relationship of these devices with kidney disease a multifaceted question relating to the use of these devices in individuals with kidney disease and to the effects of the devices and device placement on kidney health. Cardiac devices can be categorized broadly into cardiac implantable electronic devices, structural devices, and circulatory assist devices. Cardiac implantable electronic devices include devices for monitoring and managing cardiac electrical activity and devices for monitoring hemodynamics. Structural devices modify cardiac structure and include valve prostheses, valve repair clips, devices for treating atrial septal abnormalities, left atrial appendage closure devices, and interatrial shunt devices. Circulatory assist devices support the failing heart or support cardiac function during high-risk cardiac procedures. Evidence for the use of these devices in individuals with kidney disease, effects of the devices on kidney health and function, specific considerations with devices in kidney disease, and important knowledge gaps are surveyed in this article. With the growing prevalence of combined cardiorenal disease and the increasing variety of cardiac devices, kidney disease considerations are an important aspect of device therapy.

Forensic perspectives on postmortem CIED interrogation: A systematic review and meta-analysis.

BACKGROUND: Cardiac implantable electronic devices (CIED) are a heterogeneous group of medical devices with increasingly sophisticated diagnostic capabilities, which could be exploited in forensic investigations. However, current guidelines are lacking clear recommendations on the topic. The first aim of this systematic review is to provide an updated assessment of the role of postmortem CIED interrogation, and to give practical recommendations, which can be used in daily practice. Secondly, the authors aim to determine the rates of postmortem CIED interrogation and autopsy investigations, the type of final rhythm detected close to death (with a focus on the significance of documented arrhythmias), as well as the role of postmortem CIED interrogation in the determination of final cause/time of death, and any potentially fatal device malfunctions. METHODS: A systematic search in MEDLINE and Scopus aiming to identify reports concerning postmortem human CIED interrogation was performed, including a systematic screening of reference lists. Case reports, letters to the editors, commentaries, review articles or guidelines were excluded, along with studies related to cardiac devices other than CIED. All data were pooled and analyzed using fixed-effects meta-analysis models, and the I2 statistic was used to assess heterogeneity. RESULTS: A total of 25 articles were included in the systematic review, enrolling 3194 decedent CIED carriers. Ten studies (40%) had a 100% autopsy rate, whereas in further 6 studies autopsy findings were variably reported; CIED interrogation was available from 22 studies (88%), and it was never performed prior to autopsy. The overall rate of successful postmortem CIED interrogation was 89%, with high heterogeneity among studies, mainly due to device deactivation/battery discharge. Twenty-four percent of CIED carriers experienced sudden cardiac death (SCD), whereas non-sudden cardiac and non-cardiac death (NSCD, NCD) were reported in 37% and 30% of decedents, respectively. Ventricular tachyarrhythmias were recorded in 34% of overall successfully interrogated CIED, and in 62% of decedents who experienced a SCD; of all ventricular tachyarrhythmias recorded, 40% was found in NSCD or NCD. A clear interpretation of the etiological role of recorded arrhythmias in the causation of death required integration with autopsy findings. Overall, potentially fatal device malfunctions were detected in 12% of cases. CONCLUSIONS: Postmortem CIED interrogation is a valuable tool for the determination of the cause of death, and may complement autopsy. Forensic pathologists need to know the potential utility, pitfalls, and limitations of this diagnostic examination to make this tool as much reliable as possible.

Severe Tricuspid Regurgitation in a Patient with a Transvenous Dual-chamber Pacemaker: Considerations for Diagnosis and Management.

Cardiac implantable electronic device leads can contribute to tricuspid regurgitation and also complicate surgical and transcatheter interventions to manage tricuspid regurgitation. Here we present a case of a patient with sinus node dysfunction and complete heart block who underwent extraction of a right ventricular pacing lead before tricuspid valve surgery. We review the data regarding the contribution of leads to tricuspid regurgitation and the benefits of lead extraction, risks of jailing leads during tricuspid interventions, and pacing considerations around tricuspid valve procedures.

The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial.

Background: A novel non-contact system for remote parameter testing and reprogramming offers an alternative method for assessing device parameters during cardiac implantable electronic devices (CIEDs) implantation without the need for physical contact with the manufacturer's clinical service technician. The safety and feasibility of using this system in CIEDs implantation procedures remains to be determined. Objective: Evaluate the safety and feasibility of remote parameter testing in CIEDs implantation procedures. Methods: A single center, randomized, open-label, non-inferiority trial (ChiCTR2200057587) was conducted to compare the two approaches for interrogating CIEDs during implantation procedures: routine interrogation performed by on-site technicians or remote interrogation performed by technicians using the 5G-Cloud Technology Platform. Patients aged ≥18 years and elected to receive CIEDs were eligible for inclusion. The primary endpoint was the completion rate of the parameter test. Safety and efficiency were evaluated in all randomly assigned participants. Results: A total of 480 patients were finally enrolled and were randomly assigned to routine group (n = 240) or remote group (n = 240). The primary endpoint was achieved by 100% in both groups (P = 0.0060 for noninferiority). The parameters of sensing, threshold, and impedance regarding the right atrium, right ventricle, and left ventricle had no statistical significance between the two groups (P > 0.05). Procedure time, parameter testing time, and both duration and dose of x-ray irradiation were not significantly different between the two groups (P > 0.05). Shut-open door frequency was significantly higher in the routine group than the remote group [6.00 (4.00, 8.00) vs. 0, P < 0.0001]. Notably, no clinical or technical complications were observed in the remote group. Conclusions: Remote parameter testing is safe and feasible across various devices implantation procedures. The utilization of remote parameter testing and reprogramming could represent an innovative approach to improve healthcare accessibility and unlock the full potential of secondary centers in managing CIEDs. The Registration Identification: ChiCTR2200057587.